CLASS II Drug recall · Reported 11 May 2022 · FDA Enforcement Report
Losartan Potassium and Hydrochlorothiazide Tablets recalled
Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) bottles (, distributed nationwide in the US. The recall was initiated on 31 Mar 2022 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0841-2022
- FDA event ID
- 89916
- Recalling firm
- Lupin Pharmaceuticals, Baltimore, MD
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Mar 2022
- FDA classified
- 3 May 2022
- Reported
- 11 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 31 Mar 2022 | Recall initiated by company | |
| 3 May 2022 | Classified by FDA | +33 days |
| 11 May 2022 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.
Where it was distributed
Product was distributed nationwide
Questions about this recall
Why was it recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Which lots are affected?
Lot # H001149 4/30/2022 68180-215-06 H001602 5/31/2022 68180-215-06 H001884 6/30/2022 68180-215-06 H002539 8/31/2022 68180-215-06 H100944 4/30/2023 68180-215-06 H101054 4/30/2023 68180-215-06 H001150 4/30/2022 68180-215-09 H001151 4/30/2022 68180-215-09 H001152 4/30/2022 68180-215-09 H001532 5/31/2022 68180-215-09 H001533 5/31/2022 68180-215-09 H001534 5/31/2022 68180-215-09 H001535 5/31/2022 68180-215-09 H001536 5/31/2022 68180-215-09 H001603 5/31/2022 68180-215-09 H001604 5/31/2022 68180-215-09 H001605 5/31/2022 68180-215-09 H001606 5/31/2022 68180-215-09 H001607 5/31/2022 68180-215-09 H001608 5/31/2022 68180-215-09 H001885 6/30/2022 68180-215-09 H001886 6/30/2022 68180-215-09 H001887 6/30/2022 68180-215-09 H001888 6/30/2022 68180-215-09 H002171 7/31/2022 68180-215-09 H002172 7/31/2022 68180-215-09 H002173 7/31/2022 68180-215-09 H002174 7/31/2022 68180-215-09 H002175 7/31/2022 68180-215-09 H002540 8/31/2022 68180-215-09 H002541 8/31/2022 68180-215-09 H002542 8/31/2022 68180-215-09 H002543 8/31/2022 68180-215-09 H002544 8/31/2022 68180-215-09 H002545 8/31/2022 68180-215-09 H002976 10/31/2022 68180-215-09 H002977 10/31/2022 68180-215-09 H002978 10/31/2022 68180-215-09 H003131 11/30/2022 68180-215-09 H003132 11/30/2022 68180-215-09 H003133 11/30/2022 68180-215-09 H003134 11/30/2022 68180-215-09 H003135 11/30/2022 68180-215-09 H003136 11/30/2022 68180-215-09 H100302 1/31/2023 68180-215-09 H100303 1/31/2023 68180-215-09 H100304 1/31/2023 68180-215-09 H100340 1/31/2023 68180-215-09 H100341 1/31/2023 68180-215-09 H100657 2/28/2023 68180-215-09 H100658 2/28/2023 68180-215-09 H100659 2/28/2023 68180-215-09 H100660 2/28/2023 68180-215-09 H100661 2/28/2023 68180-215-09 H100662 2/28/2023 68180-215-09 H100945 4/30/2023 68180-215-09 H100946 4/30/2023 68180-215-09 H101051 4/30/2023 68180-215-09 H101052 4/30/2023 68180-215-09 H101053 4/30/2023 68180-215-09 H101055 4/30/2023 68180-215-09 H101056 4/30/2023 68180-215-09 H101057 4/30/2023 68180-215-09 H101058 4/30/2023 68180-215-09 H101286 5/31/2023 68180-215-09 H101287 5/31/2023 68180-215-09 H101288 5/31/2023 68180-215-09 H101289 5/31/2023 68180-215-09 H101581 6/30/2023 68180-215-09 H101582 6/30/2023 68180-215-09 H101583 6/30/2023 68180-215-09 H101584 7/31/2023 68180-215-09 H101585 7/31/2023 68180-215-09 H101790 7/31/2023 68180-215-09 H101791 7/31/2023 68180-215-09 H102078 8/31/2023 68180-215-09 H102079 8/31/2023 68180-215-09 H102080 9/30/2023 68180-215-09 H102118 9/30/2023 68180-215-09 H102119 9/30/2023 68180-215-09 H102120 9/30/2023 68180-215-09 H102125 9/30/2023 68180-215-09 H102126 9/30/2023 68180-215-09
Where was it sold?
Product was distributed nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 89916This product is part of a recall event; the main page for the event is Losartan Potassium Tablets USP, 100 mg, a) bottles recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Losartan Potassium Tablets USP, 100 mg, a) bottles recalledLosartan Potassium | Lupin Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | Losartan Potassium Tablets USP, 50 mg, a) bottles recalledLosartan Potassium | Lupin Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Lupin Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Lupin Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS II | Losartan Potassium Tablets USP, 25 mg, a) bottles recalledLosartan Potassium | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
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Other Losartan recalls
All 98| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium | Strides Pharma | Foreign Material | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |